Integration of Stepped Care for Perinatal Mood and Anxiety Disorders Among Women Attending MCH Clinics

Depression, Anxiety Clinical Trial

— IPMH  

Official title:

Integration of Stepped Care for Perinatal Mood and Anxiety Disorders Among Women Attending MCH Clinics

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06456307
• Other study ID #: P425/04/2023
• Secondary ID: STUDY00017933R01
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2025
• Est. completion date: March 2028

Study information

• Verified date: June 2024
• Source: Kenyatta National Hospital
• Contact: Nancy Ngumbau, MBChB, MPH
• Phone: +254713917226
• Email: nancym390[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Perinatal mood and anxiety disorders (PMAD), defined as depression and anxiety during pregnancy or up to 1 year postpartum, account for substantial morbidity and mortality among birthing people globally especially in low- and middle-income countries. Several evidence-based interventions are recommended for identification and management of PMAD by non-specialist providers in resource-limited settings. This cluster-randomized trial seeks to evaluate the effect of a stepped-care intervention for screening and treatment of PMAD among perinatal women, on clinical and implementation outcomes.

Description:

Globally, perinatal mood and anxiety disorders (PMAD) impacts 10-20% of perinatal women, with a pooled prevalence of depression at 11.9% and anxiety at 15.2%. Most of these cases go undetected and untreated since worldwide under 30% of those requiring mental health services have access to them. The Kenya Mental Health Action Plan 2021-2025 highlights a goal of expanding access to mental health services including in Maternal and Child Health clinics. In Kenya, over 95% of all pregnant women receive at least one antenatal care service from a skilled provider. However, mental health screening is not currently standardized in antenatal and postnatal care visits in Kenya, representing a missed opportunity to offer mental health services to those with PMAD symptoms. Several evidence-based interventions are recommended by the WHO for identification and management of PMAD by non-specialist providers in resource-limited settings. However, their implementation in routine care in Kenya is currently limited, due to lack of provider training and comfort with perinatal mental health treatments and poor linkage across cadres of providers (such as primary care providers and mental health providers). Sustainable integration of perinatal mental healthcare in Kenya's routine perinatal services requires development and testing of tailored interventions that strengthen workforce capacity and facilitate linkage across provider cadres, as well as implementation strategies to facilitate high-quality intervention delivery. We have identified three EBIs to promote perinatal mental health: universal WHO Mental Health Gap Action Programme (mhGAP)-recommended mental health screening, the Problem Management Plus (PM+) counseling intervention for women experiencing PMAD, and telepsychiatry for women with severe symptoms, suicidality or no response to PM+. We propose to combine these interventions in a stepped care model, named the Integrated Perinatal Mental Health program (IPMH), and develop implementation strategies to support the model's integration into routine perinatal care in Kenya. We will then evaluate IPMH's effectiveness and implementation outcomes in a Hybrid Type II trial. The study will be conducted in clinics in Kisumu, Siaya, and Homa Bay counties of Western Kenya, Kenya. Broad objective: This study seeks to evaluate the effectiveness and implementation outcomes of Integrated Perinatal Mental Health Program (universal mental health screening, problem management plus counseling intervention and tele psychiatry) in a Hybrid Type II trial. Aim 1: Using participatory design, optimize and adapt IPMH and develop implementation strategies. Aim 2: Determine the effect of IPMH and implementation strategies on mental health, HIV care, and pregnancy outcomes among perinatal women from pregnancy to 6 months postpartum. Aim 3: Determine effect of IPMH and its implementation strategies on service delivery and implementation outcomes, and identify multilevel drivers of successful implementation.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2970
• Est. completion date: March 2028
• Est. primary completion date: March 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years and older

Eligibility

Inclusion Criteria:

• Pregnant and =28 weeks gestation
• Attending ANC care at the facility
• =14 years old
• screen positive for PMAD symptoms (PHQ-2=3 and/or GAD-2=3)
• Willing to return to the MCH and PMTCT clinic for study visits

Exclusion Criteria:

• Less than 28 weeks gestation
• Any woman at high risk of self-harm based on a study self-harm assessment protocol, has cognitive impairments or psychotic symptoms

Related Conditions & MeSH terms

• Antenatal Depression
• Anxiety Disorders
• Depression
• Depression, Anxiety
• Depression, Postpartum
• Depressive Disorder
• Postnatal Depression

Intervention

Behavioral:
• Integrated Perinatal Mental health program (systematic screening for PMAD, PM+ and tele-psychiatry)
The intervention includes systematic screening for PMAD symptoms using PHQ-2 and GAD-2, non-specialist delivery of PM+ for participants with likely depression (PHQ-9=10) or anxiety (GAD-7=10) and in-facility tele-linkage to mental health specialist for participants with severe depressive symptoms (PHQ-9=15), those who endorse suicidality, or non-responders to PM+

Locations

Country	Name	City	State
Kenya	Kenyatta National Hospital	Nairobi
Kenya	HomaBay, Siaya and Kisumu	Western Kenya

Sponsors (2)

Lead Sponsor	Collaborator
Kenyatta National Hospital	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression	PHQ-9 score	6-months postpartum
Primary	Anxiety	GAD-7 score	6-months postpartum
Secondary	Quality of life	World Health Organisation Quality-of-Life Brief Version (WHOQOL-BREF) score	6-months postpartum
Secondary	Adverse pregnancy outcomes	Any adverse pregnancy outcomes defined as the following: Pregnancy loss, stillbirth, pre-term birth, low birth weight, intrauterine growth restriction, neonatal hospital admission and neonatal death	6-weeks postpartum
Secondary	Mechanism of action for PM+ (use of behavioral and psychosocial coping skills)	Reducing Tension Checklist	6-weeks postpartum